cGMP manufacturing from clinical to commercial scale
and complete process transfer and supply chain
management for ADCs including:
- Antibody development, production and testing
- Cell-line, upstream, downstream, analytical method, formulation and process development
- Manufacture of cytotoxic drug payloads
- Conjugation of antibodies with linkers and toxins
- Analytical characterization and testing
- Fill finish, labeling, packaging and storage
- Quality control and product release
- Validation of analytical methods and manufacturing processes
- Integrated project management, supply chain and registration support
CMC Biologics is an international company, originally founded in Denmark in 2001, in order to provide faster and more effective solutions to the biopharmaceutical industry’s growing need for outsourced development and manufacturing resources.
To meet the needs of a growing base of customers around the world, the company expanded into the U.S. through acquisition of facilities in Seattle. Washington and Berkeley, California.
CMC Biologics offers its clients a full suite of contract services from DNA to API and leverages its technical expertise to transform these services into solutions that meet their clients’ near- and long-term objectives.
With cGMP compliant facilities in both the United States and Europe and a team of more than 500 dedicated employees, every project is performed with absolute commitment to quality manufacturing and customer satisfaction.
Cerbios is a privately held and self-financed company, created in 1976. Located in Lugano, Switzerland, Cerbios specializes in the development and manufacture of biological and chemical APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for High Potency Active Pharmaceutical Ingredients (HPAPIs) and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides Category 4 SafeBridge® (OEL <10ng/m3), and more than two decades’ experience in HPAPI handling and manufacturing.
The company is FDA inspected, since 1996, and provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs.
Cerbios’ commercial products are marketed worldwide.
Oncotec Pharma Produktion GmbH is internationally recognized as a reliable partner for the manufacture and development of aseptically produced cytostatic drugs.
Owned through Medac and Klocke Holding, Oncotec offers a full range of services and acts as a contact point for the entire value-added chain, from development through market launch and regular production.
Since its foundation in 1997, Oncotec has steadily increased production at its Dessau-Roßlau site.
Manufacturing steps at this facility are performed on leading-edge technology production equipment under isolator protection, including three Parenteral Isolator filling lines for commercial production 28 Mio units/a.
Oncotec’s process technology covers a production area of around 1,300 m². The facility is fully compliant with global regulatory standards and regularly inspected by Saxony-Anhalt State Administration Office, holding a valid manufacturing authorization and a GMP Certificate.
IDT Biologika is a medium-sized company, founded over 95 years ago, with headquarters in Dessau, Germany. The company operates subsidiaries worldwide to continue its mission of improving the health of humans and animals through its products and services. IDT uses biotechnology to manufacture vaccines and pharmaceuticals for national and international markets.
As a global manufacturer, IDT Biologika undergoes regular inspections by clients and independent regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA); and is fully compliant with global regulatory standards.
The company’s advanced production system positions it among the world’s leading vaccine manufacturing corporations. Pioneering technologies for the production of new vaccines and pharmaceuticals underscores IDT’s commitment to set standards for pharmaceutical production, both now and in the future.
The company has nine Parenteral aseptic biological fill finish lines and 16 packaging lines, also for combination products.